Increasing Physical Activity Among Breast Cancer Survivors With Depression

Breast Cancer Clinical Trial

Official title:

Increasing Physical Activity Among Breast Cancer Survivors With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781051
• Other study ID #: STU 122015-072
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: February 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.

Description:

The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention with a 6 month follow up. Intervention components will include print-based education, self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 7, 13, and 25). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Positive depression screen (PHQ-9) or current antidepressant treatment

• Report <150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ

• Physically able to engage in physical activity

• Written and verbal fluency in English

Exclusion Criteria:

• Medical condition contraindicating physical activity participation

• Recurrence of breast cancer

• Ductal carcinoma in situ (DCIS) diagnosis

• Cognitively unable to give informed consent

• Non-English speaking

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Depression
• Depressive Disorder
• Physical Activity

Intervention

Behavioral:
• Print-based education
All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.

Device:
• Fitbit
Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.

Behavioral:
• Active Living counseling
The Active Living counseling program consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.

Other:
• Facility Access
Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer	Assess changes in physical activity at 6 months following physical activity intervention.	6 months
Secondary	Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)	Assess changes in depressive symptoms at 6 months following physical activity intervention.; Title: Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) Scoring: ranges from 0-27, higher scores indicate more severe symptomatology	6 months